Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace

The goal of this intervention study is to assess the effect of blood flow restricted (BFR) exercise integrated into the daily work tasks among hospital workers with or at increased risk of chronic knee pain.

The main questions are:

Can BFR exercise integrated into the daily work tasks reduce knee pain (primary outcome) and improve function and work ability among hospital workers with or at increased risk of chronic knee pain? Participants in the intervention group will for shorts bouts during their workdays integrate BFR into their daily work tasks involving walking, whereas the control group will continue as usual.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis; Knee Discomfort; Knee Pain Chronic
• Intervention / Treatment: Behavioral: Blood flow restriction (BFR); Behavioral: Usual care (control)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian Skovlund; Phone Number: 40385166; Email: svs@nfa.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Hospital workers working at least 20 hours per week with or without chronic knee pain (>3 months)

Exclusion Criteria:

• Life-threatening disease
• Conditions where BFR training may be contraindicated, e.g. pregnancy, cancer, diabetes, major cardiovascular disease, current, previous or family history of clotting disorders, recent immobilization, major surgery or injections into the joint (i.e. corticosteroid injection)
• Systolic/diastolic blood pressure above 160/100 mmHg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood flow restriction (BFR); Blood flow restricted training (BFR) integrated into the daily work tasks for 8 weeks.	Behavioral: Blood flow restriction (BFR); Blood flow restricted training integrated into the daily work tasks for 8 weeks.; Behavioral: Usual care (control); Will continue their work as usual
Active Comparator: Usual care (control); Will continue their work as usual	Behavioral: Usual care (control); Will continue their work as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Change in worst knee pain intensity during the last week rated on a 11-point numeric rating scale (NRS)	Change pre-post 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional performance	30-s chair-stand test, 40 m fast-paced walk test, a stair-climb test, maximal isometric knee extensor muscle strength	Change pre-post 8 weeks of intervention
Work ability	Single-item on physical work ability derived from the Work Ability Index (WAI)	Change pre-post 8 weeks of intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work-limiting pain	Rating of the degree of work limitations due to pain	Change pre-post 8 weeks of intervention
Work-related fatigue	Rating af work-related fatigue in different body parts	Change pre-post 8 weeks of intervention

Collaborators and Investigators

• Sponsor: National Research Centre for the Working Environment, Denmark
• Collaborators: University of Southern Denmark; University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start (Anticipated): April 11, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 10429; H-22016339 (Other Identifier: Regional Scientific Ethical Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No